A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia
Why are we doing this clinical trial?
COVID-19 is thought to have at least two phases: viral replication and immune response. This trial is comparing a combination of the antiviral drug remdesivir with an immune response suppressor tocilizumab to remdesivir with a placebo, in hospitalized patients with severe COVID-19 pneumonia.
To date, the FDA has issued an emergency use authorization for the use of the anti-viral drug remdesivir for the treatment of COVID-19 on the basis of multiple reports, including one in the New England Journal of Medicine, that have shown expedited recovery in patients. During viral replication, a robust immune response may be useful; however, later in the illness, a robust immune response may lead to worse symptoms.
How are patients selected to participate?
Hospitalized adult patients are identified and may be approached for inclusion in the clinical research trial if they have COVID-19 pneumonia that is causing severe illness (requiring oxygen) or critical illness (ICU admission or intensive therapies). If the patient is unable to give informed consent, patient family members will have the opportunity to opt in.
For more information about the study please email IMCPulmonaryCoordinatorTeam@imail.org.